To Evaluate the Effectiveness of New Specially Designed Fitlens Soft Lens.

Last updated: June 27, 2022
Sponsor: Fitlens Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Myopia

Treatment

N/A

Clinical Study ID

NCT05433792
FL-CN/CF-01
  • Ages 8-12
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Myopia is a common disorder, affecting approximately one-third of the US population and over 90% of the population in some East Asian countries. High amounts of myopia are associated with an increased risk of sight-threatening problems, such as retinal detachment, choroidal degeneration, cataracts, and glaucoma. Slowing the progression of myopia could potentially benefit millions of children. To date, few strategies used for myopia control have proven to be effective. Currently, there are four categories of myopia control treatments: atropine eye drops, multifocal contact lenses, multifocal eyeglasses, and orthokeratology (ortho-k). None of these modalities are US Food and Drug Administration-approved to slow myopia progression, they have been shown to slow the progression by approximately 50% with few risks. Both orthokeratology and soft bifocal contact lenses have shown to slow myopia progression by slightly less than 50% in most studies.

The Myolens progressive front soft contact lens is designed to slow down myopia progression in children, The Myolens lens is an aspheric design with a spherical back surface that provides clear vision, with a uniform round edge for excellent fit and optimum comfort.

The Myolens-CN is designed with a central for the near optics, while the Myolens-CF with a central for the distance optics, which progressively changes to far area and within a defined optical zone area while considering the movement up-down of the lens on the cornea.

The thought behind the design is that the center of the lens will not provide a full optical correction.

In the suggested study, both Myolens modalities CN and CF will be investigated in compare to the current approved treatment - MiSight.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Be between 8 and 12 years of age inclusive at baseline examination.
  2. The participant has been given a detailed, clear explanation concerning the studyaspects and procedures.
  3. The participant's parents or legal guardian have been given a clear explanation, thenread, understood, and signed the informed consent form.
  4. Willingness to adhere to protocol, agreement to maintain the visit schedule.
  5. Along with their parent or guardian, agree to maintain the visit schedule and be ableto keep all appointments as specified in the study protocol for the duration of thestudy.
  6. Agreement to wear the assigned contact lenses for a minimum of 10 hours per day, atleast 6 days per week, for the duration of the 3-year study.
  7. Subject with normal eyes who is not using any ocular medications.
  8. Possess wearable and visually functional eyeglasses.
  9. Be in good general health, based on his/her and parent's/guardian's knowledge.
  10. Best-corrected visual acuity by manifest refraction of +0.10 log MAR (20/25 or 6/7.5)or better in each eye. (Lens power required limited to up to minus 10).
  11. The manifest cylinder is less than or equal to 0,75D.
  12. Meet the following refractive criteria determined by cycloplegic autorefraction atbaseline (per eye):
  13. Spherical equivalent refractive error: between -0.75 and -4.00 D inclusive.
  14. Astigmatism: ≤-0.75 D
  15. Anisometropia: <1.00 D

Exclusion

Exclusion Criteria:

  1. Subject is currently or within 30 days before this study has been an activeparticipant in another clinical study involving an investigational treatment.
  2. Current or prior use of bifocals, progressive addition lenses, atropine, pirenzepine,or any other myopia control treatment.
  3. Birth earlier than 30 week or <1500 g (3.3 lb) at birth.
  4. Regular use of ocular medications, artificial tears, or wetting agents.
  5. Current use of systemic medications, which may affect contact lens wear, tear filmproduction, pupil size, accommodation, or refractive state.
  6. A known allergy to any of the Myolens components.
  7. A history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer,corneal infiltrates, ocular viral or fungal infections, or other recurrent ocularinfections.
  8. Strabismus by cover test at distance or near wearing distance correction.
  9. History of any of the following: ocular or systemic diseases, including those thatcould influence refractive development, anterior segment infection, inflammation orabnormality, any active anterior segment ocular disease that would contraindicatecontact lens wear; history of herpetic keratitis; history of refractive surgery orirregular cornea (except when the contact lenses under investigation are indicated forirregular cornea, keratoconus or refractive surgery); a pathologically dry eye.
  10. Keratoconus or an irregular cornea (assessed by corneas topography)
  11. Contraindications for contact lens wear including giant papillary conjunctivitis ofgrade 2 or worse and allergic or seasonal conjunctivitis (assessed by slit lamp exam)
  12. Subject seems to exhibit poor personal hygiene (that in the investigator's opinionmight prevent safe contact lens wear) or the investigator for any reason considersthat it is not in the best interest of the subject to participate in the study.
  13. Slit lamp findings that are more serious than grade 1 according to the Efron GradingScale.
  14. Corneal vascularization greater than 1 mm of penetration

Study Design

Total Participants: 66
Study Start date:
May 10, 2022
Estimated Completion Date:
January 31, 2026

Study Description

Study Procedures:

Screening period (up to 3 weeks prior to enrollment)

  1. Obtaining inform consent.

  2. Obtaining subject's relevant medical history and concomitant therapy - concurrent active medical conditions with emphasis on ocular and systemic diseases.

  3. Performance of ophthalmic examination (slit lamp), IOP, BCVA, cycloplegia refractive, axial length measurement, spherical equivalent calculation, Cover test, fundus photography and corneal topography.

  4. Confirmatiom of subject's eligiblity

  5. Subject's randomization to either of the study arms

  6. Personal fitting of the Myolens-CN/CF or MiSight as per randomization

Week 1 Day 1 (±3 days)

  1. Performance of ophthalmic examination (slit lamp), BCVA, cycloplegia refractive, axial length measurement, spherical equivalent calculation.

  2. Subject will be instructed regarding the use and handling of the lens both written and verbally.

  3. AE and concomitant therapy monitoring

Treatment period (36 months)

  1. The lenses will be worn by the subject every day, for a maximum of 14 hours per day.

  2. For the subjects allocated to either CN or CF arm, lenses will be replaced every 3 months.

  3. At M36 visit lenses will be removed.

  4. Each follow up visit will include: ophthalmic examination (slit lamp), BCVA test , axial length measurement, refractive assessment and spherical equivalence calculation, subject diary review, AE monitoring and changes in concomitant medications.

Follow up period (4 weeks) End of study (EOS) visit will be conducted 4 weeks after EOT. Completion of the study will be considered as the completion of visit 36M which will the EOT visit for the subject and 4 weeks follow up. In case of early termination, EOS will be conducted upon time of termination (UNS). EOS visit procedures are equal to 36M visit procedures.

Connect with a study center

  • Wolfson Medical Center

    Holon,
    Israel

    Active - Recruiting

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